PrisonerNCT03341702
Predictive Factors of Violence in Prison
An observational study of Prisoner, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Prison concentrates people with violent behavior and patients suffering from psychiatric disorders. Aggression are daily, the suicide rate is 5 to 10 times higher than the ordinary environment and current prevention devices have shown their limits. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prisoner
- What is being tested?
- penintetiary's incident reports collection
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2015to 1 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: male incarcerated in a french prison
Who may be able to join
- being jailed from 1st january 2012 to 31 dec 2012 in the Villeneuve Lès Maguelonne prison (Hérault, France)
Who cannot join
- opposition form, unable to understand french, age under 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Factors of Violence in Prison, Retrospective Study in an French Incarcerated Male Population
Prison concentrates people with violent behavior and patients suffering from psychiatric disorders. Aggression are daily, the suicide rate is 5 to 10 times higher than the ordinary environment and current prevention devices have shown their limits.
That's why, in order to improve the violence's prevention in prison, the investigator propose to identify the predictive factors of violence by studying retrospectively the link between the psychiatric profile and commission of violence after being jailed.
Read the detailed description
From the 1st January to the 31 December 2012, every man incarcerated was screened thanks to the Mini International Neuropsychiatric Interview (MINI) to establish the presence of a current and/or past psychiatric diagnoses. In addition, collection of violent incidents based on penitentiary's reports (aggression, suicide, self-mutilation, intoxication, murder…) was conducted .
Then statistic analysis compared psychiatric characteristics of prisoners according to whether they commit violence or not within 12 months after being jailed, distinguish the authors of self and hetero aggressive violence. Those tests are completed with a cluster analysis to precise psychiatric from criminological profiles of dangerousness.
- Conditions
- Prisoner
- Being tested
- penintetiary's incident reports collection
- Keywords
- jail, violence, predictive factors, prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
penintetiary's incident reports collectionOther
collection of clinical and penitentiary 's data
What is being measured
The primary outcome is the main question the study is designed to answer.
violent event
physical assault
Measured: within the 12 month after incarceration
violent event
suicide attempt
Measured: within the 12 month after incarceration
violent event
intoxication
Measured: within the 12 month after incarceration
violent event
violent death
Measured: within the 12 month after incarceration
violent event
sexual assault
Measured: within the 12 month after incarceration
violent event
fire
Measured: within the 12 month after incarceration
Secondary outcomes (2)
suicide attempt
according to the prison suicide attempt recording
Measured: within the 12 month after incarceration
physical assault
according to the prison suicide attempt recording
Measured: within the 12 month after incarceration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start1 Apr 2015
- Primary completion10 Oct 2017
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrisonerStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu LACAMBRE, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341702
- Sponsor's protocol ID
- RECHMPL17_0324
- Status last verified
- Oct 2017
- First submitted
- 10 Oct 2017
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Violence in Prison, Retrospective Study in an French Incarcerated Male Population
- ClinicalTrials.gov ID
- NCT03341702
- Acronym / sponsor ID
- RECHMPL17_0324
- Conditions
- Prisoner
- Keywords
- jail, violence, predictive factors, prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prison concentrates people with violent behavior and patients suffering from psychiatric disorders. Aggression are daily, the suicide rate is 5 to 10 times higher than the ordinary environment and current prevention devices have shown their limits.
That's why, in order to improve the violence's prevention in prison, the investigator propose to identify the predictive factors of violence by studying retrospectively the link between the psychiatric profile and commission of violence after being jailed.
Detailed description
From the 1st January to the 31 December 2012, every man incarcerated was screened thanks to the Mini International Neuropsychiatric Interview (MINI) to establish the presence of a current and/or past psychiatric diagnoses. In addition, collection of violent incidents based on penitentiary's reports (aggression, suicide, self-mutilation, intoxication, murder…) was conducted .
Then statistic analysis compared psychiatric characteristics of prisoners according to whether they commit violence or not within 12 months after being jailed, distinguish the authors of self and hetero aggressive violence. Those tests are completed with a cluster analysis to precise psychiatric from criminological profiles of dangerousness.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male incarcerated in a french prison
Key inclusion criteria (1 listed)
- being jailed from 1st january 2012 to 31 dec 2012 in the Villeneuve Lès Maguelonne prison (Hérault, France)
Key exclusion criteria (1 listed)
- opposition form, unable to understand french, age under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| penintetiary's incident reports collectioncollection of clinical and penitentiary 's data | Other | – |
Primary outcome
violent event
Time frame: within the 12 month after incarceration
physical assault
violent event
Time frame: within the 12 month after incarceration
suicide attempt
violent event
Time frame: within the 12 month after incarceration
intoxication
violent event
Time frame: within the 12 month after incarceration
violent death
violent event
Time frame: within the 12 month after incarceration
sexual assault
violent event
Time frame: within the 12 month after incarceration
fire
2 secondary outcomes
suicide attempt
Time frame: within the 12 month after incarceration
physical assault
Time frame: within the 12 month after incarceration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu LACAMBRE, MD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prisoner, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
violent event (time frame: within the 12 month after incarceration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.